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FDA 510(k) Application Details - K233044
Device Classification Name
More FDA Info for this Device
510(K) Number
K233044
Device Name
Tandem Mobi insulin pump with interoperable technology
Applicant
Tandem Diabetes Care Inc.
12400 High Bluff Drive
San Diego, CA 92130 US
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Contact
Louise Focht
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Regulation Number
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Classification Product Code
QFG
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Date Received
09/25/2023
Decision Date
10/05/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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